Long-Term Study to Assess Safety and Efficacy of ORX750 for Sleep Disorders

Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) are chronic neurological disorders characterized by excessive daytime sleepiness, significantly impacting quality of life. Current treatments often have limitations regarding long-term safety and sustained efficacy. This study addresses the need for extended data on novel therapies like ORX750 to ensure their long-term viability and benefit for patients.

As this study is currently RECRUITING, there are no findings to report yet. However, the study aims to establish the long-term safety profile of ORX750, including the incidence and severity of adverse events over an extended treatment period. It will also assess the sustained efficacy of ORX750 in managing core symptoms such as excessive daytime sleepiness (EDS) and cataplexy (sudden muscle weakness triggered by strong emotions, common in NT1). The primary objective is to gather crucial data on the long-term tolerability and sustained therapeutic benefits of ORX750 for individuals living with chronic sleep disorders. Secondary objectives include evaluating changes in patient-reported outcomes related to sleep quality and daily functioning, providing a comprehensive understanding of ORX750's impact beyond short-term trials. The study will monitor participants for approximately 9 months to observe any cumulative effects or changes in response to the drug.